Table 2. Key Secondary Outcome Analysis.
Outcome | No./total (%) | Risk difference, % (95% CI)a | Relative risk (95% CI)a | P valueb | |
---|---|---|---|---|---|
Minimally invasive surfactant therapy (n = 224) | Control treatment (n = 229) | ||||
Death or neurodevelopmental disabilityc,d,e | 78/215 (36.3) | 79/219 (36.1) | 0.0 (−7.6 to 7.7) | 1.00 (0.81 to 1.24) | .99 |
Death prior to 2 y corrected age | 29/224 (12.9) | 24/229 (10.5) | 2.4 (−3.6 to 8.4) | 1.23 (0.69 to 2.19) | .48 |
Neurodevelopmental disabilityc,d,e | 49/186 (26.3) | 55/195 (28.2) | −1.6 (−9.4 to 6.2) | 0.94 (0.71 to 1.25) | .69 |
Adjusted for gestational age group.
P value for relative risk derived from generalized linear model.
Neurodevelopmental disability, defined as any of (1) moderate to severe cognitive or language impairment; (2) cerebral palsy equivalent to Gross Motor Function Classification System ≥220; (3) visual impairment; and (4) hearing impairment. See eTable 1 in Supplement 3 for further details of the approach to outcome ascertainment with the different modalities of data capture.
Key secondary outcome not determinable from available follow-up data in 9 of 224 infants in the minimally invasive surfactant therapy group and 10 of 229 infants in the control group.
Neurodevelopmental disability assessment at 2 years was by online questionnaire including Parent Report of Children’s Abilities–Revised in 315 infants (minimally invasive surfactant therapy: 152, control: 163, including 64 and 69 cases, respectively, in which the questionnaire was administered using a translated version). Other modes of follow-up were face-to-face assessment including Bayley Scales of Infant and Toddler Development, Third Edition in 38 infants (minimally invasive surfactant therapy: 19, control: 19), abbreviated questionnaire in 25 (minimally invasive surfactant therapy: 14, control: 11), and a combination of modalities in 3 (minimally invasive surfactant therapy: 1, control: 2).